This skill may not reflect the latest upstream change
Federal Register Rules update on 2026-06-29 may affect this skill Last checked 6/27/2026.
manufacturing-compliance
Audit manufacturing software for FDA 21 CFR Part 11 (electronic records, e-signatures, audit trails), ISO 9001/13485/14001/45001 quality management (document control, CAPA, nonconformance), GMP batch records and cleaning validation, lot/serial traceability (forward, backward, process, recall-ready), OSHA safety (incident tracking, LOTO, PPE), hazmat handling (SDS, chemical inventory, RCRA waste), ALCOA+ data integrity, and AS9100/IATF 16949/ITAR/EAR compliance. Use when reviewing MES, ERP, quality, or production management codebases for regulatory compliance.
Signing
SignedSLSA L2- Signed by
- skills-hub.ai distributor
- Method
- Distributor-signed by skills-hub.aiCryptographically signed by the skills-hub.ai distributor key at publish time.
- Signed
Install this skill
Run this command in your terminal. No account required — it auto-detects your AI tool and installs the skill file.
npx @skills-hub-ai/cli install manufacturing-complianceSetup by platform
Install
One-click setup for your editorRun in your project root
npx @skills-hub-ai/cli install manufacturing-compliance --target claude-codeInstructions
Security
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Frequently asked questions about manufacturing-compliance
What does the manufacturing-compliance skill do?
Audit manufacturing software for FDA 21 CFR Part 11 (electronic records, e-signatures, audit trails), ISO 9001/13485/14001/45001 quality management (document control, CAPA, nonconformance), GMP batch records and cleaning validation, lot/serial traceability (forward, backward, process, recall-ready), OSHA safety (incident tracking, LOTO, PPE), hazmat handling (SDS, chemical inventory, RCRA waste), ALCOA+ data integrity, and AS9100/IATF 16949/ITAR/EAR compliance. Use when reviewing MES, ERP, quality, or production management codebases for regulatory compliance. It's a reusable SKILL.md instruction set that loads into your AI coding assistant on demand, no prompt engineering, no copy-pasting every session.
How do I install the manufacturing-compliance skill?
Run `npx @skills-hub-ai/cli install manufacturing-compliance` from your terminal. The CLI writes the SKILL.md to the correct location for your AI tool (e.g. ~/.claude/skills/manufacturing-compliance/ for Claude Code or ~/.cursor/skills/ for Cursor with --target cursor) and adds it to your project's .skills.json lockfile.
Which AI tools does manufacturing-compliance work with?
manufacturing-compliance runs in Claude Code. It follows the open Agent Skills standard (SKILL.md), so the same skill works in every supported tool without modification.
Is the manufacturing-compliance skill free?
Yes. Every skill on skills-hub.ai is free and open-source. There are no premium tiers, paywalls, or usage limits. You only pay for whatever AI assistant you're already using.
How do I use manufacturing-compliance after installing it?
In Claude Code, type `/manufacturing-compliance` (or whatever slash command the skill registers) and the AI follows the skill's instructions immediately. You can also reference it by name in natural language, your AI loads the skill into context when relevant.
Can I share the manufacturing-compliance skill with my team?
Yes. Commit your project's .skills.json lockfile and teammates run `npx @skills-hub-ai/cli install` (no args) to install every skill at the exact version you pinned. Organization-scoped installs work via skills-hub.ai organizations.